BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR HF L 3M CONNECTION CABLE

    MDR report key: 9479966 · Received December 17, 2019

    Report

    Report Number
    9479966
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    November 20, 2019
    Report Date
    December 10, 2019
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGICAL TEAM INSIDE CVOR ROOM 3. PATIENT ON CVOR TABLE, TIME OUT PERFORMED. EQUIPMENT PASSED TO CIRCULATING NURSE TO BE CONNECTED TO EQUIPMENT TOWER, SURGICAL PENCIL CORD, CAMERA CORD, LIGHT SOURCE CORD. SURGICAL PROCEDURE STARTED AT 11:52 AM. APPROXIMATELY 3 MIN AFTER PROCEDURE STARTED AT 11:55, SURGEON ATTEMPTED TO USE SURGICAL PENCIL PEDAL. THE SURGICAL PENCIL PEDAL CORD SPARKED TWICE AND A FLAME WAS NOTICED BY SURGICAL TEAM ON SURGICAL PENCIL CORD. SURGEON STOPPED THE USE OF THE DEVICE IMMEDIATELY AND A FULL ASSESSMENT OF THE PATIENT AND ROOM WAS PERFORMED. THERE WAS NO HARM TO PATIENT OR SURGICAL TEAM. SURGICAL PENCIL MACHINE, SURGICAL PENCIL PEDAL AND SURGICAL PENCIL CORD WERE EXCHANGED. SURGICAL PROCEDURE CONTINUED WITHOUT ANY OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277150 MONOPOLAR HF L 3M CONNECTION CABLE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI RICHARD WOLF GMBH 8106033

    Patients

    Seq Age Sex Outcome Treatment
    1